What changed in this filing

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Item 1. Business

2022-06-29 compared with 2021-06-14 · 606 added, 442 removed, 316 unchanged (77% of the section changed)

Pharmaceuticals, Inc., a Nevada corporation (the “Company”, “Elite”, “Elite Pharmaceuticals”, the

“registrant”, “we”, “us”

or “our”) was incorporated on October 1, 1997 under the laws

Pharmaceuticals, Inc., a Nevada corporation (the “Company”, “Elite”, “Elite Pharmaceuticals”, the

“registrant”, “we”, “us” or “our”) was incorporated on October 1, 1997 under the laws

of the State of Delaware, and its wholly-owned subsidiary, Elite Laboratories, Inc.

(“Elite Labs”), was incorporated on August

23, 1990 under the laws of the State of Delaware.

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State of Nevada.

are a specialty pharmaceutical company principally engaged in the development and manufacture of oral, controlled-release generic products,

using proprietary know-how and technology.

Our strategy includes improving off-patent drug products for life cycle management, developing

generic versions of controlled-release drug products with high barriers to entry and exploiting our proprietary and patented abuse resistance

technologies.

occupy manufacturing, warehouse, laboratory and office space at 165 Ludlow Avenue and 135 Ludlow Avenue in Northvale, NJ (the “Northvale

Facility”).

The Northvale Facility operates under Current Good Manufacturing Practice (“cGMP”) and is a United States

Drug Enforcement Agency (“DEA”) registered facility for research, development and manufacturing.

are a specialty pharmaceutical company principally engaged in the development and manufacture of oral, controlled-release products and

the manufacture of generic pharmaceuticals.

Our strategy includes developing generic versions of controlled-release drug products

with high barriers to entry.

occupy manufacturing, warehouse, laboratory and office space at 165 Ludlow Avenue and 135 Ludlow Avenue in Northvale, NJ (the “Northvale

The Northvale Facility operates under Current Good Manufacturing Practice (“cGMP”) and is a United States

Drug Enforcement Agency (“DEA”) registered facility for research, development, and manufacturing.

Our website address

is www.elitepharma.com.

focus our efforts on the following areas:

(i) manufacturing of a line of generic pharmaceutical products with approved Abbreviated New

Drug Applications (“ANDAs”);

(ii) development of additional generic pharmaceutical products;

(iii) development of the other

products in our pipeline including the products with our partners;

(iv) commercial exploitation of our products either by license and

the collection of royalties, or through the manufacture of our formulations;

and (v) development of new products and the expansion of

our licensing agreements with other pharmaceutical companies, including co-development projects, joint ventures and other collaborations.

focus is on the development of various types of drug products, including generic drug products which require ANDAs as well as branded

drug products which require New Drug Applications (“NDAs”) under Section 505(b)(1) or 505(b)(2) of the Drug Price Competition

and Patent Term Restoration Act of 1984 (the “Drug Price Competition Act”).

believe that our business strategy enables us to reduce its risk by having a diverse product portfolio that includes generic products

in various therapeutic categories and to build collaborations and establish licensing agreements with companies with greater resources

thereby allowing us to share costs of development and improve cash-flow.

products in our pipeline including products co-developed with partners;

(iv) commercial exploitation of our products either by sales

under our own label, license and the collection of royalties, or through the manufacture of our formulations;

and (v) development of

new products for sale under our own label, and the expansion of our licensing agreements with other pharmaceutical companies, including

co-development projects, joint ventures and other collaborations.

continue to evaluate opportunities for the development of various types of drug products, including branded drug products which require

New Drug Applications (“NDAs”) under Section 505(b)(1) or 505(b)(2) of the Drug Price Competition and Patent Term Restoration

Act of 1984 (the “Drug Price Competition Act”) as well as generic drug products which require ANDAs.

believe that our business strategy enables us to reduce its risk by having a diverse product portfolio that includes both branded and

generic products in various therapeutic categories and to build collaborations and establish licensing agreements with companies with

greater resources thereby allowing us to share costs of development and improve cash-flow.

own, license, contract manufacture or receive royalties from the following products currently being sold commercially:

Product Equivalent

HCl 37.5mg tablets (“Phentermine 37.5mg”)

Adipex-P ®

HCl 37.5mg tablets (“Phentermine 37.5mg”)

Phendimetrazine

Tartrate 35mg tablets (“Phendimetrazine 35mg”)

Bontril ®

HCl 15mg and 30mg capsules (“Phentermine 15mg”

and “Phentermine 30mg”)

Adipex-P ®

HCl 50mg tablets (“Naltrexone 50mg”)

2.5mg and 5mg capsules (“Isradipine 2.5mg”

and “Isradipine 5mg”)

Tartrate 35mg tablets (“Phendimetrazine 35mg”)

HCl 15mg and 30mg capsules (“Phentermine 15mg” and “Phentermine 30mg”)

HCl 50mg tablets (“Naltrexone 50mg”)

2.5mg and 5mg capsules (“Isradipine 2.5mg” and “Isradipine 5mg”)

Cardiovascular

HCl Immediate Release 5mg, 10mg, 15mg, 20mg and 30mg tablets (“OXY IR 5mg”, “Oxy IR 10mg”, “Oxy IR

15mg”, “OXY IR 20mg”

and “Oxy IR 30mg”)

Roxycodone ®

Maleate Immediate Release 25mg, 50mg and 100mg capsules (“Trimipramine 25mg”, “Trimipramine 50mg”, “Trimipramine

100mg”)

Surmontil ®

HCl Immediate Release 5mg, 10mg, 15mg, 20mg and 30mg tablets (“OXY IR 5mg”, “Oxy IR 10mg”, “Oxy IR

15mg”, “OXY IR 20mg” and “Oxy IR 30mg”)

Maleate Immediate Release 25mg, 50mg and 100mg capsules (“Trimipramine 25mg”, “Trimipramine 50mg”, “Trimipramine

Antidepressant

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Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Immediate Release 5mg, 7.5mg, 10mg, 12.5mg, 15mg,

20mg and 30mg tablets (“Amphetamine IR 5mg”, “Amphetamine IR 7.5mg”, “Amphetamine IR 10mg”, “Amphetamine

IR 12.5mg”, “Amphetamine IR 15mg”, “Amphetamine IR 20mg”

and “Amphetamine IR 30mg”)

Adderall ®

Nervous System (“CNS”) Stimulant

Sodium Capsules 25mg, 50mg and 100mg (“Dantrolene 25mg”, “Dantrolene 50mg”, Dantrolene 100mg”)

Dantrium ®

20mg and 30mg tablets (“Amphetamine IR 5mg”, “Amphetamine IR 7.5mg”, “Amphetamine IR 10mg”, “Amphetamine

IR 12.5mg”, “Amphetamine IR 15mg”, “Amphetamine IR 20mg” and “Amphetamine IR 30mg”)

Nervous System (“CNS”) Stimulant

Sodium Capsules 25mg, 50mg and 100mg (“Dantrolene 25mg”, “Dantrolene 50mg”, “Dantrolene 100mg”)

Dextroamphetamine

Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended Release 5mg, 10mg, 15mg, 20mg, 25mg, and

30mg capsules (“Amphetamine ER 5mg”, “Amphetamine ER 10mg”, “Amphetamine ER 15mg”, “Amphetamine

ER 20mg”, “Amphetamine ER 25mg”, and “Amphetamine ER 30mg”)

Nervous System (“CNS”) Stimulant

Succinate 5mg, 10mg, 25mg and 50gm capsules (“Loxapine 5mg”, “Loxapine 10mg”, “Loxapine 25mg”,

and Loxapine 50mg”)

Loxapine ®

30mg capsules (“Amphetamine ER 5mg”, “Amphetamine ER 10mg”, “Amphetamine ER 15mg”, “Amphetamine

ER 20mg”, “Amphetamine ER 25mg”, and “Amphetamine ER 30mg”)

Nervous System (“CNS”) Stimulant

Succinate 5mg, 10mg, 25mg and 50gm capsules (“Loxapine 5mg”, “Loxapine 10mg”, “Loxapine 25mg”,

and Loxapine 50mg”)

Antipsychotic

Phentermine 37.5mg is also referred to as “Phentermine Tablets”.

Phentermine 15mg and Phentermine 30mg are collectively and

individually referred to as “Phentermine Capsules”.

Phendimetrazine 35mg is also referred to as “Phendimetrazine Tablets”.

Naltrexone 50mg is also referred to as “Naltrexone Tablets”.

individually referred to as “Phentermine Capsules”.

Phendimetrazine 35mg is also referred to as “Phendimetrazine Tablets”.

Naltrexone 50mg is also referred to as “Naltrexone Tablets”.

Isradipine 2.5mg and Isradipine 5mg are collectively and individually

referred to as “Isradipine Capsules”.

Oxy IR 5mg, Oxy IR 10mg, Oxy IR 15mg Oxy IR 20mg and Oxy IR 30mg are collectively and

individually referred to as “Oxy IR”.

Trimipramine 25mg, Trimipramine 50mg, and Trimipramine 100mg are collectively and individually

referred to as “Trimipramine Capsules”.

Amphetamine IR 5mg, Amphetamine IR 7.5mg, Amphetamine IR 10mg, Amphetamine IR 12.5mg,

Amphetamine IR 15mg, Amphetamine IR 20mg and Amphetamine IR 30mg are collectively and individually referred to as “Amphetamine

IR Tablets”.

Dantrolene 25mg, Dantrolene 50mg and Dantrolene 100mg are collectively and individually referred to as “Dantrolene

Capsules”.

Amphetamine IR 15mg, Amphetamine IR 20mg and Amphetamine IR 30mg are collectively and individually referred to as “Amphetamine

Dantrolene 25mg, Dantrolene 50mg and Dantrolene 100mg are collectively and individually referred to as “Dantrolene

Amphetamine ER 5mg, Amphetamine ER 10mg, Amphetamine ER 15mg.

Amphetamine ER 20mg, Amphetamine ER 25mg and Amphetamine

ER 30mg are collectively and individually referred to as “Amphetamine ER Capsules”.

Loxapine 5gm, Loxapine 10mg, Loxapine

25mg and Loxapine 50mg are collectively and individually referred to as “Loxapine Capsules”.

approved ANDA for Phentermine 37.5mg was acquired pursuant to an asset purchase agreement with Epic Pharma LLC (“

Epic ”)

dated September 10, 2010 (the “

Phentermine Purchase Agreement ”).

25mg and Loxapine 50mg are collectively and individually referred to as “Loxapine Capsules”.

approved ANDA for Phentermine 37.5mg was acquired pursuant to an asset purchase agreement with Epic Pharma LLC (“Epic”) dated

September 10, 2010 (the “Phentermine Purchase Agreement”).

and marketing rights for Phentermine 37.5mg are included in the licensing agreement between the Company and Precision Dose Inc.

Dose ”) dated September 10, 2010 (the “

Precision Dose License Agreement ”).

Please see the section below titled

Precision Dose License Agreement ”

for further details of this agreement.

Dose”) dated September 10, 2010 (the “Precision Dose License Agreement”).

Please see the section below titled “Precision

Dose License Agreement” for further details of this agreement.

37.5mg is currently being manufactured by Elite and distributed by TAGI under the Precision Dose License Agreement.

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15mg capsules and Phentermine 30mg capsules were developed by the Company, with Elite receiving approval from the United States Food

and Drug Administration (“FDA”) of the related ANDA in September 2012.

and marketing rights for Phentermine 15mg and Phentermine 30mg are included in the Precision Dose License Agreement.

Please see the section

below titled “

Precision Dose License Agreement ”

for further details of this agreement.

below titled “ Precision Dose License Agreement ” for further details of this agreement.

15mg and Phentermine 30mg are currently being manufactured by Elite and distributed by TAGI under the Precision Dose License Agreement.

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and marketing rights for Naltrexone 50mg are included in the Precision Dose License Agreement.

Please see the section below titled “

Dose License Agreement ”

for further details of this agreement.

Please see the section below titled “ Precision

Dose License Agreement ” for further details of this agreement.

Naltrexone 50mg is currently being manufactured by Elite and

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2.5mg and Isradipine 5mg are currently a commercial product being manufactured by Elite at the Northvale Facility and distributed by

Epic Pharma LLC (“Epic”), on an exclusive basis.

5mg, Oxycodone 10mg, Oxycodone 15mg, Oxycodone 20mg and Oxycodone 30mg (“Oxy IR”)

product was an Identified IR Product in the Epic Strategic Alliance Agreement Dated March 18, 2009 (the “

Epic Strategic Alliance ”).

Methods used by Epic in the manufacture of Oxy IR were developed at the Northvale Facility pursuant to the Epic Strategic Alliance, in

which we are entitled to a Product Fee of 15% of Profits through March 2026, as defined in the Epic Strategic Alliance.

Epic Pharma LLC (“Epic”), on an exclusive basis.

5mg, Oxycodone 10mg, Oxycodone 15mg, Oxycodone 20mg and Oxycodone 30mg (“Oxy IR”)

product was an Identified IR Product in the Epic Strategic Alliance Agreement Dated March 18, 2009 (the “Epic Strategic Alliance”).Methods

used by Epic in the manufacture of Oxy IR were developed at the Northvale Facility pursuant to the Epic Strategic Alliance, in which

we are entitled to a Product Fee of 15% of Profits through March 2026, as defined in the Epic Strategic Alliance.

The first commercial

sale of Oxy IR occurred in March 2016.

Epic has reported no profit or profit split for this product since September 2019.

25mg, Trimipramine 50mg and Trimipramine 100mg

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and distributed by Epic, on an exclusive basis.

December 10, 2018, the Company received approval from the FDA for Amphetamine IR Tablets, a generic version of Adderall ®

an immediate-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine

Sulfate, Amphetamine Sulfate) with strengths of 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, and 30 mg tablets.

The product is a central

nervous system stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.

December 10, 2018, the Company received approval from the FDA for Amphetamine IR Tablets, a generic version of Adderall®, an immediate-release

mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine

Sulfate) with strengths of 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, and 30 mg tablets.

The product is a central nervous system stimulant

and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.

IR Tablets are currently a commercial product being manufactured by Elite and distributed by Lannett Company Inc.

(“Lannett”),

on an exclusive basis.

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a commercial product being manufactured by Elite at the Northvale Facility and distributed by Lannett, on an exclusive basis.

December 12, 2019, the Company received approval from the FDA for Amphetamine ER Capsules, a generic version of Adderall XR ®

an extended-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine

December 12, 2019, the Company received approval from the FDA for Amphetamine ER Capsules, a generic version of Adderall XR®, an

extended-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine

Sulfate, Amphetamine Sulfate) with strengths of 5mg, 10mg, 15mg, 20mg, 25mg, and 30 mg tablets.

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manufactured by Elite at the Northvale Facility, launched commercially in May 2021 and distributed by Burel Pharmaceuticals, Inc, an

affiliate of Prasco, LLC (“Burel”), on an exclusive basis.

Products Under FDA Review

SequestOx™

- Immediate Release Oxycodone with sequestered Naltrexone

SequestOx™

is our abuse-deterrent candidate for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.

SequestOx™

is an immediate-release Oxycodone Hydrochloride containing sequestered Naltrexone which incorporates 5mg, 10mg, 15mg, 20mg and 30mg doses

of oxycodone into capsules.

January 2016, the Company submitted a 505(b)(2) New Drug Application for SequestOx™, after receiving a waiver of the $2.3 million

filing fee from the FDA.

In March 2016, the Company received notification of the FDA’s acceptance of this filing and that such

filing has been granted priority review by the FDA with a target action under the Prescription Drug User Fee Act (“

PDUFA ”)

In March 2016, the Company received notification of the FDA’s acceptance of this filing and that such

filing has been granted priority review by the FDA with a target action under the Prescription Drug User Fee Act (“PDUFA”)

of July 14, 2016.

July 15, 2016, the FDA issued a Complete Response Letter, or CRL, regarding the NDA.

The CRL stated that the review cycle for the SequestOx™

NDA is complete and the application is not ready for approval in its present form.

July 7, 2017, the Company reported topline results from a pivotal bioequivalence fed study for or SequestOx™.

The mean Tmax (the

amount of time that a drug is present at the maximum concentration in serum) of SequestOx TM was 4.6 hr.

with a range of 0.5

and the mean Tmax of the comparator, Roxicodone®, was 3.4 hr.

amount of time that a drug is present at the maximum concentration in serum) of SequestOx™ was 4.6 hr.

with a range of 0.5 hr.

A key objective for

the study was to determine if the reformulated SequestOx TM had a similar Tmax to the comparator when taken with a high fat

Based on these results, the Company paused clinical trials for this formulation of SequestOx™.

On January 30, 2018, the Company

reported positive topline results from a pilot study conducted for a modified SequestOx™

wherein, based on the results of this

pilot study, the modified SequestOx™

formulation is expected to achieve bioequivalence with a Tmax range equivalent to the reference

product when conducted in a pivotal trial under fed conditions.

The FDA has provided guidance for repeated bio-equivalence studies in

order to bridge the new formulation to the original SequestOx™

studies and also extended our filing fee waiver until July 2020.

Due to the prohibitive cost of such repeated bio-equivalence studies, the Company has paused development of this product.

and the mean Tmax of the comparator, Roxicodone®, was 3.4 hr.

with a range of 0.5 hr.

A key objective for the

study was to determine if the reformulated SequestOx™ had a similar Tmax to the comparator when taken with a high fat meal.

on these results, the Company paused clinical trials for this formulation of SequestOx™.

On January 30, 2018, the Company reported

positive topline results from a pilot study conducted for a modified SequestOx™ wherein, based on the results of this pilot study,

the modified SequestOx™ formulation is expected to achieve bioequivalence with a Tmax range equivalent to the reference product

when conducted in a pivotal trial under fed conditions.

The Company has provided the pilot data to the FDA, requesting clarification

as to the requirements for resubmission of the NDA.

The FDA has provided guidance for repeated bio-equivalence studies in order to bridge

the new formulation to the original SequestOx™ studies and also extended our filing fee waiver until July 2023.

Due to the prohibitive

cost of such repeated bio-equivalence studies and the uncertain commercial viability given the regulatory and competitive landscape,

the Company has paused development of this product.

can be no assurances of the Company conducting future clinical trials, or if such trials are conducted, there can be no assurances of

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be in amounts that provide adequate return on the significant investments made to secure this marketing authorization.

Hydrochloride extended release (generic version of Oxycontin ®

September 20, 2017, the Company filed an ANDA with the FDA for generic version of Oxycontin®

(extended release Oxycodone Hydrochloride).

OxyContin®

is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and

Hydrochloride extended release (generic version of OxyContin®)

September 20, 2017, the Company filed an ANDA with the FDA for generic version of OxyContin® (extended release Oxycodone Hydrochloride).

OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and

for which alternative treatment options are inadequate.

IMS reported approximately $2.3 billion in revenue for OxyContin®

IMS reported approximately $2.3 billion in revenue for OxyContin® and its

equivalents in 2016.

The FDA requested additional information relating to this filing, compliance with which would require significant

Development of this product is currently paused, with the Company evaluating the feasibility of the continued development

of this product.

version of an antibiotic product

January 3, 2019, the Company filed an ANDA with the FDA for a generic version of an antibiotic product.

According to QVIA (formerly QuintilesIMS

Health) data, the branded product for this antibiotic and its equivalents had total annual U.S.

sales of approximately $85 million for

the twelve months ending September 30, 2019.

The product is jointly owned by Elite and SunGen Pharma LLC.

Upon approval by the FDA of

this ANDA, Elite will manufacture and package the product on a cost-plus basis.

The ANDA is currently under review by the FDA.

can be no assurances that any of these products will receive marketing authorization and achieve commercialization within this time period,

Development of this product has been reinitiated with a target filing in Q1 2023 .

can be no assurances that any of these products will receive marketing authorization and achieve commercialization.

In addition, even if marketing authorization is received, there can be no assurances that there will be future revenues or

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and Codeine Phosphate

Company received approval from the FDA of an ANDA for a generic version of Tylenol®

with Codeine (acetaminophen and codeine phosphate)

300mg/7.5mg, 300mg/15mg, 300mg/30mg and 300mg/60mg tablets.

Acetaminophen with codeine is a combination medication indicated for

the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate.

Company received approval on September 10, 2019 from the FDA of an ANDA for a generic version of Tylenol® with Codeine (acetaminophen

and codeine phosphate) 300mg/7.5mg, 300mg/15mg, 300mg/30mg and 300mg/60mg tablets.

Acetaminophen with codeine is a combination medication

indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments

are inadequate.

Acetaminophen with codeine products have annual U.S.

sales of approximately $45 million according to IQVIA (formerly QuintilesIMS Health

sales of approximately $45 million according to IQVIA (formerly

QuintilesIMS Health Data).

The Company is not pursuing licensing deals for any opioids at this time until the market changes.

The Company will wait for the

market to stabilize before pursuing these opportunities.

will wait for the market to stabilize before pursuing these opportunities.

can be no assurances in relation to any of the above approved products not yet commercialized, that there will be future revenues of

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made to secure these marketing authorizations.

version of an antibiotic product

January 3, 2019, the Company filed an ANDA with the FDA for a generic version of an antibiotic product.

According to QVIA (formerly QuintilesIMS

Health) data, the branded product for this antibiotic and its equivalents had total annual U.S.

sales of approximately $85 million for

the twelve months ending September 30, 2019.

The product is jointly owned by Elite and Praxgen

Pharmaceuticals LLC, formerly SunGen Pharma LLC, (“Praxgen”) .

The product was approved in April 2022.

and Transferred Products

part of standard operating practices, the Company, from time to time, as relevant, conducts evaluations of all ANDAs owned, consisting,

without limitation, of ANDAs acquired or approved prior to the fiscal year ended March 31, 2021 (“Fiscal 2021”) and ANDAs

without limitation, of ANDAs acquired or approved prior to the fiscal year ended March 31, 2022 (“Fiscal 2022”) and ANDAs

acquired or approved during the Fiscal 2022.

Such evaluations include, without limitation, costs and benefits relating to each ANDA owned,

with such costs including those fees required under the FDA’s Generic Drug User Fee Amendment (“GDUFA”) which is significantly

influenced by the number of ANDAs owned, and other costs and benefits taking into consideration various specific market factors for each

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Manufacturing and Development Agreements

and Distribution Licensing Agreement with Epic Pharma LLC for SequestOx™

June 4, 2015, we executed an exclusive License Agreement (the “

2015 SequestOx™

License Agreement ”) with Epic,

to market and sell in the U.S., SequestOx™, an immediate release oxycodone with sequestered naltrexone capsule, owned by us.

2015 SequestOx ™

License Agreement expired on June 4, 2020.

During the term of this agreement, the Company received $7.5

million in non-refundable payments, with such amount consisting of $5 million due and owing on the execution date of the 2015 SequestOx™

License Agreement and $2.5 million being earned upon the Company’s filing of an NDA with the FDA for the relevant product in

January 2016.

The remaining $7.5 million in non-refundable payments required FDA approval of the relevant product, a milestone that was

not achieved prior to the expiration of the agreement.

Dose License Agreement

September 10, 2010, we executed a License Agreement with Precision Dose (the “

Precision Dose License Agreement ”) to

market and distribute Phentermine 37.5mg, Phentermine 15mg, Phentermine 30mg, Hydromorphone 8mg, Naltrexone 50mg, and certain additional

products that require approval from the FDA, through its wholly-owned subsidiary, TAGI, in the United States, Puerto Rico and Canada.

Phentermine 37.5mg was launched in April 2011.

September 10, 2010, we executed a License Agreement with Precision Dose (the “Precision Dose License Agreement”) to market

and distribute Phentermine 37.5mg, Phentermine 15mg, Phentermine 30mg, Hydromorphone 8mg, Naltrexone 50mg, and certain additional products

that require approval from the FDA, through its wholly-owned subsidiary, TAGI, in the United States, Puerto Rico and Canada.

37.5mg was launched in April 2011.

Hydromorphone 8mg was launched in March 2012.

Phentermine 15mg and Phentermine 30mg were

launched in April 2013.

Phentermine 15mg and Phentermine 30mg were launched

in April 2013.

Naltrexone 50mg was launched in September 2013.

Precision Dose will have the exclusive right to market these

products in the United States and Puerto Rico and a non-exclusive right to market the products in Canada.

Precision Dose will have the exclusive right to market these products

in the United States and Puerto Rico and a non-exclusive right to market the products in Canada.

to the Precision Dose License Agreement, Elite will receive a license fee and milestone payments.

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The milestone payments will be

paid in six instalments.

The first instalment was paid upon execution of the Precision Dose License Agreement.

The remaining instalments

paid in six installments.

The first installment was paid upon execution of the Precision Dose License Agreement.

The remaining installments

are to be paid upon FDA approval and initial shipment of the products to Precision Dose.

The term of the Precision Dose License Agreement

is 15 years and may be extended for three successive terms, each of five years.

Development and License Agreement with SunGen Pharma LLC

August 24, 2016, as amended we entered into an agreement with SunGen Pharma LLC (“SunGen”) (the “SunGen Agreement”)

to undertake and engage in the research, development, sales and marketing of eight generic pharmaceutical products.

Two of the products

are classified as CNS stimulants (the “CNS Products”), two of the products are classified as beta blockers and the remaining

four products consist of antidepressants, antibiotics and antispasmodics.

The Company has received approval from the FDA for Amphetamine

IR Tablets, Amphetamine ER Capsules and has filed an ANDA for an antibiotic product.

the terms of the SunGen Agreement, Elite and SunGen will share in the responsibilities and costs in the development of these products

and will share substantially in the profits from sales.

Upon approval, the know-how and intellectual property rights to the products

will be owned jointly by Elite and SunGen.

Three of the eight products will be jointly owned, three products will be owned by SunGen,

with Elite having exclusive marketing rights and the remaining two products will be owned by Elite, with SunGen having exclusive marketing

Elite will manufacture and package all eight products on a cost-plus basis.

December 10, 2018, the Company received approval from the FDA for Amphetamine IR Tablets, a generic version of Adderall ®

an immediate-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine

Sulfate, Amphetamine Sulfate) with strengths of 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, and 30 mg tablets.

The product is a central

nervous system stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.

is jointly owned by Elite and SunGen.

Elite manufactures and packages this product, at the Northvale Facility, on a cost-plus basis,

and it is currently sold pursuant to the Lannett Alliance, with the first commercial shipment of this product occurring in April 2019.

Please see the section below titled “Strategic Marketing Alliance with Lannett Company Inc.”

for further details on the Lannett

January 3, 2019, the Company filed an ANDA with the FDA for a generic version of an antibiotic product.

According to QVIA (formerly QuintilesIMS

Health) data, the branded product for this antibiotic and its equivalents had total annual U.S.

sales of approximately $94 million for

the twelve months ending September 30, 2018.

The product is jointly owned by Elite and SunGen.

Upon approval by the FDA of this ANDA,

Elite will manufacture and package the product on a cost-plus basis.

The ANDA is currently under review by the FDA.

December 12, 2019, the Company received approval from the FDA for Amphetamine ER Capsules, a generic version of Adderall XR ®

an extended-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine

Sulfate, Amphetamine Sulfate) with strengths of 5mg, 10mg, 15mg, 20mg, 25mg and 30mg capsules.

The product is a central nervous system

stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The product is jointly owned by

Elite and SunGen.

Elite manufactures and packages this product, at the Northvale Facility, on a cost plus basis and it is currently sold

pursuant to the Lannett Alliance, with the first commercial shipment of this product occurring in March 2020.

Please see the section

below titled “Strategic Marketing Alliance with Lannett Company Inc.”

for further details on the Lannett Alliance.

April 3, 2020, Elite and SunGen mutually agreed to discontinue any further joint product development activities under the SunGen Agreement

except for the antibiotic tablet product which has been filed with the FDA and the antibiotic capsule product not yet filed.

products remain jointly owned assets of the parties.

May 2020, SunGen, under an asset purchase agreement, assigned its rights and obligations under the SunGen Agreement for Amphetamine IR

and Amphetamine ER to Mikah Pharmaceuticals.

The ANDAs for Amphetamine IR and Amphetamine ER are now registered under Elite’s name.

Mikah will now be Elite’s partner with respect to Amphetamine IR and ER and will assume all the rights and obligations for these

products from SunGen.

can be no assurances that any of these products will receive marketing authorization and achieve commercialization within this time period,

In addition, even if marketing authorization is received, and even for those products for which marketing authorization has

already been received, there can be no assurances that there will be future revenues or profits, or that any such future revenues or

profits would be in amounts that provide adequate return on the significant investments made to secure these marketing authorizations

or provide sufficient financial contributions to support costs of operations and overheads.

Marketing Alliance with Glenmark Pharmaceuticals, Inc.

May 22, 2018, and as amended on August 1, 2018, we entered into a license, manufacturing and supply agreement with Glenmark Pharmaceuticals

Glenmark ”) to market the two Elite generic products described below in the United States with the option

to add products in the future (the “

Glenmark Alliance ”).

The license for Methadone Tablets was terminated by mutual

agreement in December 2019.

The license for Phendimetrazine Capsules was terminated by mutual agreement in February 2020.

for Trimipramine Capsules and Isradipine Capsules expired in May 2021.

the term of the Glenmark Alliance, Glenmark had exclusive marketing rights to the following products:

Methadone Tablets, Trimipramine

Capsules and Isradipine Capsules.

Glenmark also had semi-exclusive marketing rights to Phendimetrazine Tablets.

All products included

in the Glenmark Alliance were manufactured by Elite.

In addition to the purchase prices for the products, Elite also received license

fees in excess of 50% of gross profits, with such being defined as net sales less the price paid to Elite for the products, distribution

fees of less than 10% and shipping costs.

is 15 years and may be extended for 3 successive terms, each of 5 years.

License with Epic Pharma LLC

November 21, 2020 we entered into a license, manufacturing and supply agreement with Epic Pharma LLC (“

Epic ”) to market

the two Elite generic products described below in the United States (the “

Epic Pharma License ”).

November 21, 2020 we entered into a license, manufacturing and supply agreement with Epic Pharma LLC (“Epic”) to market the

two Elite generic products described below in the United States (the “Epic Pharma License”).

on May 23, 2021 and continuing until the agreement terminates, Epic has exclusive marketing rights to Trimipramine Capsules and Isradipine

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LLC and its affiliate Burel Pharmaceuticals, Inc.

Burel ”) to market generic Loxapine Succinate capsules in the United

States (the “

Burel License ”).

Burel sales for the product began May 2021.

(“Burel”) to market generic Loxapine Succinate capsules in the United States

(the “Burel License”).

Burel sales for the product began in May 2021.

the agreement, Burel has exclusive marketing rights to Loxapine.

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Company has entered into two separate license, supply and distribution agreements with Lannett Company Inc.

(“Lannett”).

The first agreement, dated March 6, 2019, relates to products that were co-developed with SunGen (the “Lannett-SunGen Product Alliance”).

The second agreement, dated April 9, 2019, relates to products that were solely developed by Elite (the “Lannett-Elite Product

Alliance”).

Both agreements are collectively and individually referred to as the “Lannett Alliance”).

Lannett-SunGen Product Alliance, Lannett will be the exclusive U.S.

distributor for Amphetamine IR Tablets and Amphetamine ER Capsules.

Elite manufactures these products, which are purchased, marketed and distributed by Lannett under the Lannett label.

In addition to the

purchase prices for the products, Elite will receive license fees well in excess of 50% of net profits, which will be shared equally

with SunGen, pursuant to the SunGen Agreement.

Net profits are defined as net sales less the price paid to Elite for the products, distribution

fees (less than 10%) and shipping costs.

The Lannett-SunGen Product Alliance has an initial term of three years and automatically renews

for one year periods absent prior written notice of non-renewal.

In addition to customary termination provisions, the Agreement permits

Lannett to terminate with regard to a product on at least three months’

prior written notice if it determines to stop marketing

and selling such product, and it permits Elite to terminate with regard to a product if at any time after the first twelve months from

the first commercial sale, the average license fee paid by Lannett for such product is less than $100,000 for a six month sales period.

In addition to manufacturing fees and license fees, Lannett also paid a $750,000 milestone, upon the March 2020 commercial launch of

The first agreement, dated March 6, 2019, relates to products that were co-developed with Praxgen

(the “Lannett- Praxgen Product Alliance”).

The second agreement, dated April 9, 2019, relates to products

that were solely developed by Elite (the “Lannett-Elite Product Alliance”).

Both agreements are collectively and individually

referred to as the “Lannett Alliance”).

to Lannett- Praxgen Product Alliance with Lannett, Lannett will be the exclusive U.S.

distributor for Amphetamine IR Tablets and

Amphetamine ER Capsules.

This milestone payment was earned during March 2020 and was shared equally by Elite and SunGen, pursuant to

the SunGen Agreement.

first commercial shipment of Amphetamine IR Tablets, a generic version of Adderall ®

, with strengths of 5mg, 7.5mg, 10mg,

12.5mg, 15mg, 20mg and 30mg, pursuant to the Lannett-SunGen Product Alliance occurred in April 2019.

first commercial shipment of Amphetamine ER Capsules, a generic version of Adderall XR ®

, with strengths of 5mg, 10mg,

15mg, 20mg, 25mg and 30mg, pursuant to the Lannett-SunGen Product Alliance occurred in March 2020.

Elite manufactures these products, which are purchased, marketed and distributed by Lannett under the Lannett

In addition to the purchase prices for the products, Elite will receive license fees well in excess of 50% of net profits, which

will be shared equally with Praxgen, pursuant to the Praxgen Agreement.

Net profits are defined as net sales less the price

paid to Elite for the products, distribution fees (less than 10%) and shipping costs.

The Lannett- Praxgen Product Alliance has

an initial term of three years and automatically renews for one year periods absent prior written notice of non-renewal.

to customary termination provisions, the Agreement permits Lannett to terminate with regard to a product on at least three months’

prior written notice if it determines to stop marketing and selling such product, and it permits Elite to terminate with regard to a

product if at any time after the first twelve months from the first commercial sale, the average license fee paid by Lannett for such

product is less than $100,000 for a six month sales period.

In addition to manufacturing fees and license fees, Lannett also paid a $750,000

milestone, upon the March 2020 commercial launch of Amphetamine ER Capsules.

This milestone payment was earned during March 2020 and

was shared equally by Elite and Praxgen, pursuant to the Praxgen Agreement.

first commercial shipment of Amphetamine IR Tablets, a generic version of Adderall®, with strengths of 5mg, 7.5mg, 10mg, 12.5mg,

15mg, 20mg and 30mg, pursuant to the Lannett- Praxgen Product Alliance occurred in April 2019.

first commercial shipment of Amphetamine ER Capsules, a generic version of Adderall XR®, with strengths of 5mg, 10mg, 15mg, 20mg,

25mg and 30mg, pursuant to the Lannett- Praxgen Product Alliance occurred in March 2020.

to the Lannett-Elite Product Alliance, Lannett will be the exclusive U.S.

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of Dantrolene Capsules, with strengths of 25mg, 50mg and 100mg occurred in June 2019.

to the Lannett-Elite Product Alliance, Elite manufactures for Lannett’s purchase, marketing, and distribution of Dantrolene Capsules

under the Lannett label.

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In addition to customary

termination provisions, the Agreement permits Lannett to terminate with regard to a product on at least three months’

prior written

termination provisions, the Agreement permits Lannett to terminate with regard to a product on at least three months’ prior written

notice if it determines to stop marketing and selling such product, and it permits Elite to terminate with regard to a product if at

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In addition to manufacturing fees and license fees.

also note that in May 2020, SunGen, under an asset purchase agreement, assigned its rights and obligations under the SunGen Agreement

for Amphetamine IR and Amphetamine ER to Mikah Pharmaceuticals.

also note that in May 2020, Praxgen, under an asset purchase agreement, assigned its rights and obligations under the Praxgen

Agreement for Amphetamine IR and Amphetamine ER to Mikah.

The ANDAs for Amphetamine IR and Amphetamine ER are now registered under

Elite’s name.

Mikah will now be Elite’s partner with respect to Amphetamine IR and ER and will assume all the rights and

obligations for these products from SunGen.

Elite’s name.

Mikah will now be Elite’s partner with respect to Amphetamine IR and ER and will assume all the rights and

obligations for these products from Praxgen.

Under Development

Elite’s

research and development activities include developing its proprietary abuse deterrent technology and the development of a range of abuse

deterrent opioid products that utilize this technology or other approaches to abuse deterrence.

Elite’s

proprietary abuse-deterrent technology utilizes the pharmacological approach to abuse deterrence and consists of a multi-particulate

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filed an NDA for the first product to utilize our abuse deterrent technology, Immediate Release Oxycodone 5mg, 10mg, 15mg, 20mg and 30mg

with sequestered Naltrexone (collectively and individually referred to as “

SequestOx™

”), on January 14, 2016.

Please see “

Filed products under FDA review;

SequestOx™

- Immediate Release Oxycodone with sequestered Naltrexone ”

above and please note that continued development of this product is currently paused.

Company is currently not selling opioids nor are we pursuing licensing deals for opioids until the market conditions improve.

we have divested some opioid products.

The Company will wait for the market to stabilize before pursuing these opportunities.

January 3, 2019, the Company filed an Abbreviated New Drug Application with the US Food and Drug Administration for a generic version

of an antibiotic product.

Please see “

Filed products under FDA review ”

Please note that there can

be no assurances of this product receiving marketing authorization or achieving commercialization.

In addition, even if marketing authorization

is received and the product is commercialized, there can be no assurances of future revenues or profits in such amounts that would provide

adequate return on the significant investments made to secure marketing authorization for this product.

Please also see the section below

titled “

Master Development and License Agreement with SunGen Pharma LLC ”.

with sequestered Naltrexone (collectively and individually referred to as “SequestOx™”), on January 14, 2016.

see “Filed products under FDA review;

SequestOx™ - Immediate Release Oxycodone with sequestered Naltrexone” above and

please note that continued development of this product is currently paused.

Company is currently not selling and is evaluating the market place when deciding to proceed with the above listed filed applications.

note that, while the FDA is required to review applications within certain timeframes, during the review process, the FDA frequently

requests that additional information be submitted.

The effect of such request and subsequent submission can significantly extend the

time for the NDA review process.

Until an NDA is actually approved, there can be no assurances that the information requested and submitted

will be considered adequate by the FDA to justify approval.

The packaging and labeling of our developed products are also subject to

FDA regulation.

Based on the foregoing, it is impossible to anticipate the amount of time that will be needed to obtain FDA approval

to market any product.

In addition, there can be no assurances of the Company filing the required application(s) with the FDA or of the

FDA approving such application(s) if filed, and the Company’s ability to successfully develop and commercialize products incorporating

its abuse deterrent technology is subject to a high level of risk as detailed in “

Item 1A-Risk Factors-Risks Related to our

Business ”

of this Annual Report on Form 10-K.

The effect of such requests and subsequent submissions can significantly

extend the time for the FDA review process.

Until a product is actually approved, there can be no assurances that the information

requested and submitted will be considered adequate by the FDA to justify approval.

The packaging and labeling of our approved

products are also subject to FDA regulation.

Based on the foregoing, it is impossible to anticipate the amount of time that will be needed

to obtain FDA approval and to commercialize a product, if approved.

In addition, there can be no assurances of the Company filing

the required application(s) with the FDA or of the FDA approving such application(s) if filed.

The Company’s ability

to successfully develop and commercialize products incorporating its abuse deterrent technology is subject to a high level of risk as

detailed in “Item 1A-Risk Factors-Risks Related to our Business” of this Annual Report on Form 10-K.

Abuse-Deterrent

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Both, agonist, and antagonist, have been on the market for a number of years and sold separately in various dose strengths.

Company is currently not selling opioids nor are we pursuing licensing deals for opioids until the market conditions improve.

we have divested some opioid products.

The Company will wait for the market to stabilize before pursuing these opportunities.

Company is currently not selling opioids and is evaluating the market place when deciding to proceed with the above listed filed applications.

our incorporation, we have secured the following patents, of which two have been assigned for a fee to another pharmaceutical company.

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We have also filed corresponding foreign applications for key patents.

to the enactment in the United States of new laws adopting certain changes mandated by the General Agreement on Tariffs and Trade (“

GATT ”),

to the enactment in the United States of new laws adopting certain changes mandated by the General Agreement on Tariffs and Trade (“GATT”),

the exclusive rights afforded by a U.S.

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such patents and compete with us using the resulting alternative technology.

SequestOx™

is a trademark owned by Elite.

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Regulation and Approval

design, development, and marketing of pharmaceutical compounds, on which our success depends, are intensely regulated by governmental

regulatory agencies, in particular the FDA.

Non-compliance with applicable requirements can result in fines and other judicially imposed

sanctions, including product seizures, injunction actions and criminal prosecution based on products or manufacturing practices that

violate statutory requirements.

In addition, administrative remedies can involve voluntary withdrawal of products, as well as the refusal

of the FDA to approve ANDAs and NDAs.

The FDA also has the authority to withdraw approval of drugs in accordance with statutory due process

a drug may be marketed, it must be approved by the FDA either by an NDA or an ANDA, each of which is discussed below.

design, development, manufacturing, and marketing of pharmaceutical compounds, on which our success depends, are intensely regulated

by governmental regulatory agencies, in particular the FDA and DEA.

Non-compliance with applicable requirements can result in

fines and other judicially imposed sanctions, including product seizures, injunction actions and criminal prosecution based on products

or manufacturing practices that violate statutory requirements.

In addition, administrative remedies can involve voluntary withdrawal

of products, as well as the refusal of the FDA to approve ANDAs and NDAs.

The FDA also has the authority to withdraw approval of drugs

in accordance with statutory due process procedures.

a drug may be marketed, it must be approved by the FDA either through an NDA or an ANDA, each of which is discussed below.

and NDAs under Section 505(b)(2) of the Drug Price Competition Act

FDA approval procedure for an NDA is generally a two-step process.

During the Initial Product Development stage, an investigational new

drug application (“

IND ”) for each product is filed with the FDA.

A 30-day waiting period after the filing of each

IND is required by the FDA prior to the commencement of initial clinical testing.

If the FDA does not comment on or question the IND

within such 30-day period, initial clinical studies may begin.

If, however, the FDA has comments or questions, they must be answered

to the satisfaction of the FDA before initial clinical testing may begin.

In some instances, this process could result in substantial

delay and expense.

Initial clinical studies generally constitute Phase I of the NDA process and are conducted to demonstrate the product

tolerance/safety and pharmacokinetic in healthy subjects.

Phase I testing, extensive efficacy and safety studies in patients must be conducted.

After completion of the required clinical testing,

an NDA is filed, and its approval, which is required for marketing in the United States, involves an extensive review process by the

The NDA itself is a complicated and detailed application and must include the results of extensive clinical and other testing, the

cost of which is substantial.

However, the NDA filings contemplated by us, which are already marketed drugs, would be made under Sections

505 (b)(1) or 505 (b)(2) of the Drug Price Competition Act, which do not require certain studies that would otherwise be necessary;

the development timetable should be shorter.

While the FDA is required to review applications within a certain timeframe, during the

review process, the FDA frequently requests that additional information be submitted.

The effect of such request and subsequent submission

can significantly extend the time for the NDA review process.

Until an NDA is approved, there can be no assurance that the information

requested and submitted will be considered adequate by the FDA to justify approval.

The packaging and labelling of our developed products

are also subject to FDA regulation.

It is impossible to anticipate the amount of time that will be needed to obtain FDA approval to market

During the initial product development stage, an investigational

new drug application (“IND”) for each product is filed with the FDA.

The IND contains results of animal and in vitro studies

assessing the toxicology, pharmacokinetic, pharmacological, and pharmacodynamics characteristics of the product candidate;

manufacturing, and controls information;

and any available human data or literature to support the use of the product candidate.

A 30-day waiting period after the filing of each IND is required by the FDA prior to the commencement of initial clinical testing.

the FDA does not comment on or question the IND within such 30-day period, initial clinical studies may begin.

If, however, the FDA has

comments or questions, they must be answered to the satisfaction of the FDA before initial clinical testing may begin.

In some instances,

this process could result in substantial delay and expense.

Clinical trials are typically conducted in three sequential phases that

may overlap or be combined:

The product candidate is initially introduced into healthy human subjects or patients with the target disease or condition.

These studies are designed to test the safety, dosage tolerance, absorption, metabolism, and distribution of the investigational product

in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.

In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically

administer to healthy volunteers, the initial human testing;

The product candidate is administered to a limited patient population with a specified disease or condition to evaluate the

preliminary efficacy, optimal dosages, and dosing schedule and to identify possible adverse side effects and safety risks.

Multiple Phase

2 clinical trials may be conducted to obtain information prior to beginning;

The product candidate is administered to an expanded patient population to further evaluate dosage, to provide statistically

significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial

These clinical trials are intended to establish the overall risk.

with clinical trials, companies usually complete additional animal studies and must also develop additional information about the chemistry

and physical characteristics of the drug and finalize a process for manufacturing the product in commercial quantities in accordance

with cGMP requirements.

The manufacturing process must be capable of consistently producing quality batches of the product candidate

and, among other things, the manufacturer must develop methods for testing the identity, strength, quality, and purity of the final drug.

In addition, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product

candidate does not undergo unacceptable deterioration over its shelf life.

successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development

nonclinical and clinical trials, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry of

the drug, proposed labeling and other relevant information are submitted to the FDA as part of an NDA requesting approval to market the

The submission of an NDA is subject to the payment of substantial user fees;

a waiver of such fees may be obtained under certain

limited circumstances.

FDA reviews an NDA to determine, among other things, whether a product is safe and effective for its intended use and whether its manufacturing

is cGMP-compliant to assure and preserve the product’s identity, strength, quality, and purity.

Under the Prescription Drug User

Fee Act, or PDUFA, guidelines that are currently in effect, the FDA has a goal of ten months from the date of “filing” of

a standard NDA for a new molecular entity to review and act on the submission.

This review typically takes 12 months from the date the

NDA is submitted to FDA because the FDA has approximately two months to make a “filing” decision after the application is

The FDA conducts a preliminary review of all NDAs within the first 60 days after submission, before accepting them for filing,

to determine whether they are sufficiently complete to permit substantive review The FDA may request additional information rather than

accept an NDA for filing.

In this event, the NDA must be resubmitted with the additional information.

The resubmitted application is

also subject to review before the FDA accepts it for filing.

FDA may refer an application for a novel drug to an advisory committee.

An advisory committee is a panel of independent experts, including

clinicians and other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be

approved and under what conditions.

The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations

carefully when making decisions.

approving an NDA, the FDA will typically inspect the facility or facilities where the product is manufactured.

The FDA will not approve

an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP and adequate to assure

consistent production of the product within required specifications.

Additionally, before approving an NDA, the FDA will typically inspect

one or more clinical sites to assure compliance with GCPs.

If the FDA determines that the application, manufacturing process, or manufacturing

facilities are not acceptable, it will outline the deficiencies in the submission and often will request additional testing or information.

Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy

the regulatory criteria for approval.

the FDA evaluates an NDA, it will issue an approval letter or a Complete Response Letter.

An approval letter authorizes commercial marketing

of the drug with prescribing information for specific indications.

A Complete Response Letter indicates that the review cycle of the

application is complete, and the application will not be approved in its present form.

A Complete Response Letter usually describes the

specific deficiencies in the NDA identified by the FDA and may require additional clinical data, such as an additional pivotal Phase

3 clinical trial or other significant and time-consuming requirements related to clinical trials, nonclinical studies, or manufacturing.

If a Complete Response Letter is issued, the sponsor must resubmit the NDA, addressing all of the deficiencies identified in the letter,

or withdraw the application.

Even if such data and information are submitted, the FDA may decide that the NDA does not satisfy the criteria

for approval.

regulatory approval of a product is granted, such approval will be granted for particular indications and may entail limitations on the

indicated uses for which such product may be marketed.

For example, the FDA may approve the NDA with a REMS to ensure the benefits of

the product outweigh its risks.

A REMS is a safety strategy to manage a known or potential serious risk associated with a medicine and

to enable patients to have continued access to such medicines by managing their safe use.

It could include medication guides, physician

communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries, and other risk minimization

The FDA also may offer conditional approval subject to, among other things, changes to proposed labeling or the

development of adequate controls and specifications.

Once approved, the FDA may withdraw the product approval if compliance with pre-

and post-marketing requirements is not maintained or if problems occur after the product reaches the marketplace.

The FDA may also require

one or more Phase 4 post-market studies and surveillance to further assess and monitor the product’s safety and effectiveness after

commercialization, and may limit further marketing of the product based on the results of these post-marketing studies.

new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change,

which could impact the timeline for regulatory approval or otherwise impact ongoing development programs.

FDA closely regulates the marketing, labeling, advertising, and promotion of drug products.

A company can make only those claims relating

to safety and efficacy that are approved by the FDA and in accordance with the provisions of the approved label.

The FDA and other agencies

actively enforce the laws and regulations prohibiting the promotion of off-label uses.

Failure to comply with these requirements can

result in, among other things, adverse publicity, warning letters, corrective advertising, and potential civil and criminal penalties.

Physicians may prescribe, in their independent professional medical judgment, legally available products for uses that are not described

in the product’s labeling and that differ from those tested by us and approved by the FDA.

Physicians may believe that such off-label

uses are the best treatment for many patients in varied circumstances.

The FDA does not regulate the behavior of physicians in their

choice of treatments.

The FDA does, however, restrict manufacturer’s communications on the subject of off-label use of their products.

The federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and

has enjoined companies from engaging in off-label promotion.

The FDA and other regulatory agencies have also required that companies

enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed.

However, companies

may share truthful and not misleading information that is otherwise consistent with a product’s FDA-approved labeling.

or not FDA approval has been obtained, approval of the product by comparable regulatory authorities in any foreign country must be obtained

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products become commercially available.

FDA approval procedure for an ANDA differs from the procedure for an NDA in that the FDA waives the requirement of conducting complete

clinical studies, although it normally requires bioavailability and/or bioequivalence studies.

Bioavailability ”

the rate and extent of absorption and levels of concentration of a drug product in the blood stream needed to produce a therapeutic effect.

Bioequivalence ”

compares the bioavailability of one drug product with another, and when established, indicates that

the rate of absorption and levels of concentration of the active drug substance in the body are equivalent for the generic drug and the

previously approved drug.

An ANDA may be submitted for a drug on the basis that it is the equivalent of a previously approved drug or,

in the case of a new dosage form, is suitable for use for the indications specified.

timing of final FDA approval of an ANDA depends on a variety of factors, including whether the applicant challenges any listed patents

for the drug and whether the brand-name manufacturer is entitled to one or more statutory exclusivity periods, during which the FDA may

be prohibited from accepting applications for, or approving, generic products.

In certain circumstances, a regulatory exclusivity period

can extend beyond the life of a patent, and thus block ANDAs from being approved on the patent expiration date.

under Section 505(b)(2)

505(b)(2) NDAs may provide an alternate path to FDA approval for new or improved formulations or new uses of previously approved products.

Section 505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from clinical trials

not conducted by, or for, the applicant and for which the applicant has not obtained a right of reference.

The FDA may then approve the

new product candidate for all, or some, of the label indications for which the referenced product has been approved, as well as for any

new indication sought by the Section 505(b)(2) applicant.

the extent that the Section 505(b)(2) applicant is relying on the FDA’s findings of safety and effectiveness for an already approved

product, the applicant is required to certify to the FDA concerning any patents listed for the approved product in the Orange Book to

the same extent that an ANDA applicant would.

Thus approval of a Section 505(b)(2) NDA can be stalled until all the listed patents claiming

the referenced product have expired;

until any non-patent exclusivity, such as exclusivity for obtaining approval of a NCE, listed in

its publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” also referred to as the “Orange

Book,” for the referenced product has expired;

and, in the case of a Paragraph IV certification and subsequent patent infringement

suit, until the earlier of 30 months, settlement of the lawsuit or a decision in the infringement case that is favorable to the Section

505(b)(2) applicant.

In the interim period, the FDA may grant tentative approval.

Tentative approval indicates that the FDA has determined

that the applicant meets the standards for approval as of the date that the tentative approval is granted.

Final regulatory approval

can only be granted if the FDA is assured that there is no new information that would affect final regulatory/ approval.

obtain approval of a generic drug, an applicant must submit an abbreviated new drug application, or ANDA, to the agency.

comprehensive submission that contains, among other things, data and information pertaining to the active pharmaceutical ingredient,

bioequivalence, drug product formulation, specifications and stability of the generic drug, as well as analytical methods, manufacturing

process validation data and quality control procedures.

ANDAs are “abbreviated” because they cannot include preclinical and

clinical data to demonstrate safety and effectiveness.

Instead, in support of such applications, a generic manufacturer must rely on

the preclinical and clinical testing previously conducted for a drug product previously approved under an NDA, known as the reference

listed drug, or RLD.

order for an ANDA to be approved, the FDA must find that the generic version is identical to the RLD with respect to the active ingredients,

the route of administration, the dosage form, the strength of the drug and the conditions of use of the drug.

At the same time, the FDA

must also determine that the generic drug is “bioequivalent” to the innovator drug.

Under the statute, a generic drug is

bioequivalent to a RLD if “the rate and extent of absorption of the drug do not show a significant difference from the rate and

extent of absorption of the listed drug.” Upon approval of an ANDA, the FDA indicates whether the generic product is “therapeutically

equivalent” to the RLD in the Orange Book.

Physicians and pharmacists consider a therapeutic equivalent generic drug to be fully

substitutable for the RLD.

In addition, by operation of certain state laws and numerous health insurance programs, the FDA’s designation

of therapeutic equivalence often results in substitution of the generic drug without the knowledge or consent of either the prescribing

physician or patient.

an ANDA applicant submits its application to the FDA, it is required to certify to the FDA concerning any patents listed for the reference

product in the FDA’s Orange Book.

Specifically, the ANDA applicant must certify that:

(i) the required patent information has not

(ii) the listed patent has expired;

(iii) the listed patent has not expired, but will expire on a particular date and approval

is sought after patent expiration;

or (iv) the listed patent is invalid or will not be infringed by the new product.

the follow-on applicant does not challenge the innovator’s listed patents, FDA will not approve the ANDA application until all

the listed patents claiming the referenced product have expired.

A certification that the new product will not infringe the already approved

product’s listed patents, or that such patents are invalid, is called a Paragraph IV certification.

If the follow-on applicant

has provided a Paragraph IV certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the NDA

and patent holders once the ANDA has been accepted for filing by the FDA.

The NDA and patent holders may then initiate a patent infringement

lawsuit in response to the notice of the Paragraph IV certification.

The filing of a patent infringement lawsuit within 45 days of the

receipt of a Paragraph IV certification automatically prevents the FDA from approving the ANDA until the earlier of 30 months, expiration

of the patent, settlement of the lawsuit, or a decision in the infringement case that is favorable to the ANDA applicant.

May 1992, Congress enacted the Generic Drug Enforcement Act of 1992, which allows the FDA to impose debarment and other penalties on

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We do not believe that we receive any services from any debarred

are also subject to federal, state, and local laws of general applicability, such as laws relating to working conditions.

licensed by, registered with, and subject to periodic inspection and regulation by the Drug Enforcement Agency (“

and New Jersey state agencies, pursuant to federal and state legislation relating to drugs and narcotics.

Certain drugs that we currently

develop or may develop in the future may be subject to regulations under the Controlled Substances Act and related statutes.

As we manufacture

such products, we may become subject to the Prescription Drug Marketing Act, which regulates wholesale distributors of prescription drugs.

facilities and manufacturing techniques used for the manufacture of products for clinical use or for sale must be operated in conformity

with cGMP regulations issued by the FDA.

We engage in manufacturing on a commercial basis for distribution of products and operate our

facilities in accordance with cGMP regulations.

If we hire another company to perform contract manufacturing for us, we must ensure that

our contractor’s facilities conform to cGMP regulations.

federal Controlled Substances Act of 1970, or CSA, and its implementing regulations establish a “closed system” of regulations

for controlled substances.

The CSA imposes registration, security, recordkeeping and reporting, storage, manufacturing, distribution,

importation, exportation, disposal and other requirements under the oversight of the Drug Enforcement Agency, or DEA.

The DEA is the

federal agency responsible for regulating controlled substances, and requires those individuals or entities that manufacture, import,

export, distribute, research, or dispense controlled substances to comply with the regulatory requirements in order to prevent the diversion

of controlled substances to illicit channels of commerce.

DEA categorizes controlled substances into one of five schedules — Schedule I, II, III, IV or V — with

varying qualifications for listing in each schedule.

Schedule I substances by definition have a high potential for abuse, have no currently

accepted medical use in treatment in the United States and lack accepted safety for use under medical supervision.

Pharmaceutical products

having a currently accepted medical use that are otherwise approved for marketing may be listed as Schedule II, III, IV or V substances,

with Schedule II substances presenting the highest potential for abuse and physical or psychological dependence, and Schedule V substances

presenting the lowest relative potential for abuse and dependence.

The regulatory requirements are more restrictive for Schedule II substances

than Schedule III-V substances.

that manufacture, distribute, import or export any controlled substance must register annually with the DEA.

The DEA registration is

specific to the particular location, activity(ies) and controlled substance schedule(s).

For example, separate registrations are required

for importation and manufacturing activities, and each registration authorizes which schedules of controlled substances the registrant

Certain coincident activities are permitted without obtaining a separate DEA registration, however, such as distribution

of controlled substances by the manufacturer that produces them.

DEA inspects all manufacturing facilities to review security, recordkeeping, reporting and handling prior to issuing a controlled substance

registration.

The specific security requirements vary by the type of business activity and the schedule and quantity of controlled substances

The most stringent requirements apply to manufacturers of Schedule I and Schedule II substances.

Required security measures

commonly include background checks on employees and physical control of controlled substances through storage in approved vaults, safes

and cages, and through use of alarm systems and surveillance cameras.

Once registered, manufacturing facilities must maintain records

documenting the manufacture, receipt and distribution of all controlled substances.

Manufacturers must submit periodic reports to the

DEA of the distribution of Schedule I and II controlled substances, Schedule III narcotic substances, and other designated substances.

Registrants must also report any controlled substance thefts or significant losses, and must obtain authorization to destroy or dispose

of controlled substances.

drugs manufactured in the United States, the DEA establishes annually an aggregate quota for the amount of substances within Schedules

I and II that may be manufactured or produced in the United States based on the DEA’s estimate of the quantity needed to meet legitimate

medical, scientific, research and industrial needs.

The quotas apply equally to the manufacturing of the active pharmaceutical ingredient

and production of dosage forms.

The DEA may adjust aggregate production quotas, and individual manufacturing or procurement quotas from

time to time, although the DEA has substantial discretion in whether or not to make such adjustments for individual companies.

quota system was amended in 2018 to require sponsors to strengthen controls over diversion of controlled substances, controls and limits

the availability and production of controlled substances in Schedule I or II.

In November 2017, the DEA reduced the amount of almost

every Schedule II opiate and opioid medication that may be manufactured in the U.S.

in calendar year 2018 by 20%.

For 2019, the DEA proposed

decreased manufacturing quotas for the six most frequently misused opioids, including oxycodone, by an average of 10% as compared to

the 2018 quotas.

The DEA proposed further decreasing manufacturing quotas in 2020 for five of the six opioids (fentanyl, hydrocodone,

hydromorphone, oxycodone, oxymorphone), by an average of 28%.

In October 2019, the DEA proposed additional regulations to amend the manner

in which the agency grants quotas to manufacturers.

The proposed regulations will establish use-specific quotas, including commercial

sales, product development, transfer, replacement and packaging.

To decrease the risk of diversion and increase accountability, inventory

allowances will be reduced, and procurement quota certifications will be required.

In April 2020 in response to the COVID-19 pandemic,

the DEA adjusted the established 2020 aggregate production quotas and assessment of annual needs for select Schedule II substances.

DEA took this action to ensure that the country has an adequate and uninterrupted supply of these substances during the public health

laws have been enacted to address the national epidemics of prescription opioid abuse and illicit opioid use.

In 2016, the Comprehensive

Addiction and Recovery Act (“CARA”), was enacted to address the national epidemics of prescription opioid abuse and heroin

CARA expands the availability of naloxone for law enforcement and other first responders, forms an interagency task force to develop

best practices for pain management with opioid medications and provides resources to improve state monitoring of opioids.

The Substance

Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”), which

was signed into law in November 2018, includes a number of measures directed towards regulation and improvement of treatment for substance

use-disorder and increased coverage by CMS of medically-assisted treatment options.

In addition, the SUPPORT Act requires HHS to report

to Congress on existing barriers to access to abuse-deterrent opioid formulations by Medicare Part C and D beneficiaries

states also maintain separate controlled substance laws and regulations, including licensing, recordkeeping, security, distribution,

and dispensing requirements.

State authorities, including Boards of Pharmacy, regulate use of controlled substances in each state.

to maintain compliance with applicable requirements, particularly as manifested in the loss or diversion of controlled substances, can

result in enforcement action that could have a material adverse effect on business, operations and financial conditions.

seek civil penalties, refuse to renew necessary registrations, or initiate proceedings to revoke those registrations.

In certain circumstances,

violations could lead to criminal prosecution.

Healthcare Laws and Compliance Requirements

activities are subject to various federal and

state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute, the federal civil False Claims Act, and

laws and regulations pertaining to limitations on and reporting of healthcare provider payments (physician sunshine laws).

and regulations are interpreted and enforced by various federal, state and local authorities including CMS, the Office of Inspector General

Department of Health and Human Services, the U.S.

Department of Justice, individual U.S.

Attorney offices within the Department

of Justice, and state and local governments.

These laws include:

federal Anti-Kickback Statute, which prohibits, among other things, persons or entities

from knowingly and willfully soliciting, offering, receiving or paying any remuneration,

directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either

the referral of an individual for, or the purchase, lease, order, or arranging for or recommending

the purchase, lease or order of, any good or service, for which payment may be made, in whole

or in part, under federal healthcare programs such as Medicare and Medicaid.

entity does not need to have actual knowledge of the statute or specific intent to violate

it in order to have committed a violation;

civil False Claims Act (which can be enforced through “qui tam,” or whistleblower

actions, by private citizens on behalf of the federal government), prohibits any person from,

among other things, knowingly presenting, or causing to be presented false or fraudulent

claims for payment of government funds or knowingly making, using or causing to be made or

used, a false record or statement material to an obligation to pay money to the government

or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money

federal government;

federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes

criminal liability and amends provisions on the reporting, investigation, enforcement, and

penalizing of civil liability for, among other things, knowingly and willfully executing,

or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly

and willfully falsifying, concealing or covering up a material fact or making any materially

false statement, in connection with the delivery of, or payment for healthcare benefits,

items or services by a healthcare benefit program, which includes both government and privately

funded benefits programs;

similar to the U.S.

federal Anti-Kickback Statute, a person or

entity does not need to have actual knowledge of the statute or specific intent to violate

it in order to have committed a violation;

laws and regulations, including state anti-kickback and false claims laws, that may apply

to our business practices, including but not limited to, research, distribution, sales and

marketing arrangements and claims involving healthcare items or services reimbursed by any

third-party payer, including private insurers;

state laws that require pharmaceutical companies

to comply with the pharmaceutical industry’s voluntary compliance guidelines and the

relevant compliance guidance promulgated by the U.S.

federal government, or otherwise restrict

payments that may be made to healthcare providers and other potential referral sources;

state laws and regulations that require drug manufacturers to file reports relating to pricing

and marketing information, which requires tracking gifts and other remuneration and items

of value provided to healthcare professionals and entities;

Physician Payments Sunshine Act, implemented as the Open Payments program, and its implementing

regulations, requires certain manufacturers of drugs, devices, biologics and medical supplies

that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance

Program to report annually to CMS information related to certain payments made in the preceding

calendar year and other transfers of value to physicians and teaching hospitals, as well

as ownership and investment interests held by physicians and their immediate family members;

beginning in 2022, applicable manufacturers are required to report such information regarding

payments and transfers of value provided, as well as ownership and investment interests held,

during the previous year to physician assistants, nurse practitioners, clinical nurse specialists,

certified nurse anesthetists, and certified nurse-midwives.

of any of these laws or any other governmental regulations that may apply to us, may subject us to significant civil, criminal and administrative

sanctions including penalties, damages, fines, imprisonment, and exclusion from government funded healthcare programs, such as Medicare

and Medicaid, and/or adverse publicity.

government entities and private litigants have asserted claims under state consumer protection statutes against pharmaceutical companies

for alleged false or misleading statements in connection with the marketing, promotion and/or sale of pharmaceutical products, including

state investigations and litigation by certain government entities regarding the marketing of opioid products.

Corrupt Practices Act

Foreign Corrupt Practices Act, or the FCPA, generally prohibits offering, promising, giving, or authorizing others to give anything of

value, either directly or indirectly, to a non-U.S.

government official in order to influence official action, or otherwise obtain or

retain business.

The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the transactions

of the corporation and to devise and maintain an adequate system of internal accounting controls.

Our industry is heavily regulated and

therefore involves significant interaction with public officials, including officials of non-U.S.

Additionally, in many

other countries, the health care providers who prescribe pharmaceuticals are employed by their government, and the purchasers of pharmaceuticals

are government entities;

therefore, our dealings with these prescribers and purchasers are subject to regulation under the FCPA.

the SEC and Department of Justice have increased their FCPA enforcement activities with respect to pharmaceutical companies.

could result in fines, criminal sanctions against us, our officers, or our employees, the closing down of our facilities, requirements

to obtain export licenses, cessation of business activities in sanctioned countries, implementation of compliance programs, and prohibitions

on the conduct of our business.

Enforcement actions may be brought by the Department of Justice or the Securities and Exchanges Commission

(“SEC”), and recent enacted legislation has expanded the SEC’s power to seek disgorgement in all FCPA cases filed in

federal court and extended the statute of limitations in SEC enforcement actions in intent-based claims such as those under the FCPA

from five years to ten years.

and Reimbursement

of any pharmaceutical product depend, in part, on the extent to which such product will be covered by third-party payors, such as federal,

state, and foreign government healthcare programs, commercial insurance, and managed healthcare organizations, and the level of reimbursement

for such product by third-party payors.

Significant uncertainty exists as to the coverage and reimbursement status of any newly approved

Decisions regarding the extent of coverage and amount of reimbursement to be provided for any product are made on a plan-by-plan

One third-party payor’s decision to cover a particular product does not ensure that other payors will also provide coverage

for the product.

As a result, the coverage determination process can require manufacturers to provide scientific details, information

on cost-effectiveness, and clinical support for the use of a product to each payor separately.

This can be a time-consuming process,

with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance.

addition, third-party payors are increasingly reducing reimbursements for pharmaceutical products and related services.

and state legislatures have continued implementing cost-containment programs, including price controls and restrictions on coverage and

reimbursement.

Third-party payors are increasingly challenging the prices charged, examining the medical necessity and reviewing the

cost effectiveness of pharmaceutical products, in addition to questioning their safety and efficacy.

Adoption of price controls and cost-containment

measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit sales of

Decreases in third-party reimbursement for any product or a decision by a third-party payor not to cover a product could

reduce physician usage and patient demand for the product.

expect that additional federal, state and foreign healthcare reform measures will be adopted in the future, any of which could limit

the amounts that third-party payors, including government payors, will pay for healthcare products and services, which could result in

limited coverage and reimbursement and reduced demand for our products, once approved, or additional pricing pressures.

with Environmental Laws

are subject to comprehensive federal, state and local environmental laws and regulations that govern, among other things, air polluting

emissions, wastewater discharges, solid and hazardous waste disposal, and the remediation of contamination associated with current or

emissions, waste water discharges, solid and hazardous waste disposal, and the remediation of contamination associated with current or

past generation handling and disposal activities, including the past practices of corporations as to which we are the legal successor

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addition to competitors that are developing products based on drug delivery technologies, there are also companies that have announced

that they are developing opioid abuse-deterrent products that might compete directly or indirectly with Elite’s products.

include, but are not limited to Pfizer Inc., Collegium Pharmaceuticals, Inc., and Purdue Pharma LP.

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The principal competitive factors in the generic pharmaceutical market include:

(i) introduction of other generic drug manufacturers’

products in direct competition with our products under development, (ii)

(i) introduction of other generic drug manufacturers’ products in direct competition with our products under development, (ii)

introduction of authorized generic products in direct competition with any of our products under development, particularly if such products

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and retail customers, to switch among pharmaceutical manufacturers, (vi) pricing pressures and product deletions by competitors, (vii)

a company’s reputation as a manufacturer and distributor of quality products, (viii) a company’s level of service (including

maintaining sufficient inventory levels for timely deliveries), (ix) product appearance and labelling and (x) a company’s breadth

a company’s reputation as a manufacturer and distributor of quality products, (viii) a company’s level of service (including

maintaining sufficient inventory levels for timely deliveries), (ix) product appearance and labelling and (x) a company’s breadth

of product offerings.

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relative instability of some foreign governments and economies;

price volatility based on labor unrest, materials or equipment shortages, export duties, restrictions on the transfer of funds, or

fluctuations in currency exchange rates;

regarding recourse to a dependable legal system for the enforcement of contracts and other rights.

price volatility based on labor unrest, materials or equipment shortages, export duties,

restrictions on the transfer of funds, or fluctuations in currency exchange rates;

● Uncertainty

regarding recourse to a dependable legal system for the enforcement of contracts and other

we currently obtain the raw materials that we need from over 20 suppliers, some materials used in our products are currently available

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We have registered our facilities with the FDA and

see the Risk Factor in Part I, Item 1A entitled “We are dependent on a small number of customers, suppliers and other third parties

for core business aspects”

see the Risk Factor in Part I, Item 1A entitled “ We are dependent on a small number of customers, suppliers and other third

parties for core business aspects.

on One or a Few Major Customers

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We have agreements with Lannett

Epic Pharma, Burel Pharmaceuticals and Precision Dose for the licensing, sales and distribution of products that we manufacture.

revenues to manufacture these products and also receive a profit split or royalties based on in-market sales of the products.

see the Risk Factor in Part I, Item 1A entitled We are dependent on a small number of customers, suppliers and other third parties for

core business aspects”

Company, Prasco, LLC, Epic Pharma, LLC, and TAGI Pharma, LLC for the licensing, sales and distribution of products that we manufacture.

We receive revenues to manufacture these products and also receive a profit split or royalties based on in-market sales of the products.

Please see the Risk Factor in Part I, Item 1A entitled “ We are dependent on a small number of customers, suppliers and other

third parties for core business aspects.

Reporting Segments

We currently operate in two

segments, which are products whose marketing approvals were secured via an ANDA and products whose marketing approvals were secured via

ANDA products are referred to as generic pharmaceuticals and NDA products are referred to as branded pharmaceuticals.

years ended March 31, 2021 and 2020 revenue from our ANDA segment were $25.2 million and $17.0 million, respectively.

For the years ended

March 31, 2020 and 2019 revenue from our NDA segment were $0.2 million and $1.0 million, respectively.

currently operate in two segments, which are products whose marketing approvals were secured via an ANDA and products whose marketing

approvals were secured via an NDA.

ANDA products are referred to as generic pharmaceuticals and NDA products are referred to as branded

pharmaceuticals.

For the years ended March 31, 2022 and 2021 revenue from our ANDA segment were $32.3 million and $25.2 million, respectively.

For the years ended March 31, 2022 and 2021 revenue from our NDA segment were $0.0 million and $0.2 million, respectively.

information is consistent with the financial information regularly reviewed by our chief operating decision maker, who we have determined

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decision maker does not review this information by segment.

As of June 7, 2021, we had

43 full time employees.

of June 15, 2022, we had 43 full time employees.

Full-time employees are engaged in operations, administration, research, and development.

None of our employees

is represented by a labor union and we have never experienced a work stoppage.

We believe our relationship with our employees to be good.

However, our ability to achieve our financial and operational objectives depends in large part upon our continuing ability to attract,

integrate, retain, and motivate highly qualified personnel, and upon the continued service of our senior management and key personnel.

None of our employees is represented by a labor union and we have never experienced a work stoppage.

We believe our relationship with

our employees to be good.

However, our ability to achieve our financial and operational objectives depends in large part upon our continuing

ability to attract, integrate, retain, and motivate highly qualified personnel, and upon the continued service of our senior management

and key personnel.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business